Flucloxacillin 250mg capsules

United Kingdom - English - eMC (Electronic Medicines Compendium)

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Active ingredient:
Flucloxacillin sodium
Available from:
Noumed Life Sciences Ltd
ATC code:
J01CF05
INN (International Name):
Flucloxacillin sodium
Dosage:
250mg
Pharmaceutical form:
Capsule
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 05010102; GTIN: 05060453460177 05060453460498
Authorization number:
PL 44041/0017

Package leaflet: Information for the patient

Flucloxacillin

Flucloxacillin 250 mg and 500 mg Capsules

What is in this leaflet:

1. What Flucloxacillin Capsules are and what are they used for

2. What you need to know before you take Flucloxacillin Capsules

3. How to take Flucloxacillin Capsules

4. Possible side effects

5. How to store Flucloxacillin Capsules

6. Contents of the pack and other information

1.

What Flucloxacillin Capsules are and what are they used

for

Flucloxacillin is an antibiotic used to treat infections by killing

bacteria that can cause them. It belongs to a group of antibiotics

called “penicillins”.

Flucloxacillin is used to treat:

chest infections

throat or nose infections

ear infections

skin and soft tissue infections

heart infections

bone and joint infections

meningitis

digestive system infections

blood infections

kidney, bladder or urethra (the tube which carries urine from

the bladder) infections.

Flucloxacillin may also be used to prevent infections during major

surgery, particularly heart or orthopaedic surgery.

2.

What you need to know before you take Flucloxacillin

Capsules

Do not take Flucloxacillin Capsules if:

You are allergic to flucloxacillin or any other penicillin

antibiotics (see symptoms in section 4).

You are allergic to any of the other ingredients of this medicine

(listed in section 6).

You have suffered previously from liver problems (e.g.

jaundice) after taking flucloxacillin.

Warnings and precautions

Talk to your doctor or pharmacist before taking Flucloxacillin

Capsules if:

You are taking or will be taking paracetamol

There is a risk of blood and fluid abnormality (high anion gap

metabolic acidosis) which occurs when there is an increase in

plasma acidity, when flucloxacillin is used concomitantly with

paracetamol, particularly in certain groups of patients at risk,

e.g. patients with severe renal impairment, sepsis or

malnutrition, especially if the maximum daily doses of

paracetamol are used. High anion gap metabolic acidosis is a

serious disease that must have urgent treatment.

You suffer from kidney problems, as you may require a lower

dose than normal

You suffer from liver problems, as this medicine could cause

them to worsen

You are 50 years of age or older

You have other serious illnesses (apart from the infection this

medicine is treating)

You are taking this medicine for a long time as regular tests of

liver and kidney function are advised

You are on a low sodium diet

Other medicines and Flucloxacillin Capsules

Tell your doctor or pharmacist before taking this medicine if you

are taking any other medicines, especially:

Probenecid or sulfinpyrazone (used to treat gout)

Methotrexate (a chemotherapy drug)

The contraceptive pill as antibiotics can make these less

effective (you will need to use extra precautions such as

condoms while taking flucloxacillin and for a full 7 days after

you finish taking it)

Oral typhoid vaccine (antibiotics can make this less effective)

Sugammadex (used with general anaesthetics)

Piperacillin (an antibiotic taken by injection)

Warfarin (medicine to prevent blood clotting)

Some medicines may affect the way others work. Tell your doctor

or pharmacist if you are taking, have recently taken or might take

any other medicines. This means medicines you have bought

yourself as well as medicines on prescription from a doctor.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant

or are planning to have a baby, ask your doctor or pharmacist for

advice before taking this medicine.

Driving and using machines

Flucloxacillin Capsules should not affect your ability to drive or

operate machinery

Flucloxacillin Capsule contains sodium

Each 250mg capsule contains 13mg of sodium and each 500mg

capsule contain 25mg of sodium. To be taken into consideration by

patients on a controlled sodium diet.

3.

How to take Flucloxacillin Capsules

Always take this medicine exactly as your doctor or pharmacist

has told you.

Their directions may differ from the information contained in this

leaflet. The pharmacist’s label should tell you how much to take

and how often. Check with your doctor or pharmacist if you are

not sure.

Take this medicine when your stomach is empty. This means an

hour before food or 2 hours after food. It is important that you take

your medicine at the right times. The capsules should be

swallowed whole with water.

The dose will depend on the patient and will be decided by your

doctor. However, the usual doses for each age group are:

Adults including older patients

The usual dose for adults, older patients and children over 10 years

old is one 250 mg capsule four times a day. Your doctor may

increase the dosage depending on your infection.

For bone or heart infections the dose is up to 8g daily, in divided

doses at six to eight hours apart.

For preventing infections during surgery the dose is 1 to 2g given

into a vein at the same time as anaesthesia followed by 500 mg

every six hours for up to 72 hours.

Use in children

For children 2 to 10 years old the dose is half of the adult dose. For

children under 2 years old the dose is quarter of the adult dose.

Your doctor may prescribe a syrup formulation for children

younger than 10 years.

Patients with kidney problems

If you suffer from severe kidney failure your doctor will give you

lower or fewer doses.

If you take more Flucloxacillin Capsules than you should

If you have taken more capsules than you should, talk to your

pharmacist or doctor immediately.

Read all of this leaflet carefully before you start taking this

medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or

pharmacist.

This medicine has been prescribed for you only. Do not pass

it on to others. It may harm them, even if their signs of illness

are the same as yours.

If you get any side effects, talk to your doctor or pharmacist.

This includes any possible side effects not listed in this

leaflet. See section 4.

5.

How to store Flucloxacillin Capsules

Keep this medicine out of the sight and reach of children.

Do not store above 25°C. Store in the original pack.

Do not use Flucloxacillin Capsules after the expiry date which is

stated on the carton or label after EXP. The expiry date refers to

the last day of that month.

Do not throw away any medicines via wastewater or household

waste. Ask your pharmacist how to throw away medicines you no

longer use. These measures will help to protect the environment.

6.

Contents of the pack and other information

What Flucloxacillin Capsules contain:

The active substance in Flucloxacillin 250 mg & 500 mg

Capsules is flucloxacillin sodium.

The other ingredients are Colloidal anhydrous silica,

Magnesium stearate, gelatin, Black Iron oxide (E172),

Titanium dioxide (E171), Iron Oxide Red (E172), Iron Oxide

Yellow (E172). The white ink contains titanium dioxide

(E171), Shellac, Tween 80.

What Flucloxacillin Capsules look like and contents of the

pack

Flucloxacillin 250 mg Capsules are caramel and black and are

printed with the words ‘FLU250MIL’

Flucloxacillin 500 mg Capsules are caramel and black and printed

with the words ‘FLU500MIL’

Flucloxacillin 250 mg Capsules are available in blister packs

containing 20 or 28 Capsules.

Flucloxacillin 500 mg Capsules are available in blister packs

containing 20 or 28 Capsules.

Not all pack sizes may be marketed.

This leaflet was last revised in July 2018.

Marketing Authorisation Holder and Manufacturer:

NOUMED LIFE SCIENCES LIMITED

Noumed House, Shoppenhangers Road,

Maidenhead, Berkshire, SL6 2RB, United Kingdom

To listen to or request a copy of this leaflet in

braille, large print or audio,

please call 020 33 99 8960 (UK only).

Please be ready to give the following information

Product name

Reference number

Flucloxacillin 250 mg Capsules PL 44041/0017

Flucloxacillin 500 mg Capsules PL 44041/0018

If you forget to take Flucloxacillin Capsules

If you have missed a dose, do not take a double dose to make up

for the missed dose. If you forget to take a dose take it as soon as

you remember it and carry on as before.

If you stop taking your medicine

Keep taking your medicine until your doctor tells you to stop. Do

not stop taking it just because you feel better. If you stop taking

the medicine, your infection may return or get worse. If you are

still unwell after taking all the medicine, go and see your doctor.

If you have any further questions on the use of this medicine, ask

your doctor or pharmacist.

4.

Possible side effects

Like all medicines, Flucloxacillin Capsules can cause side effects,

although not everybody gets them. If they occur, they are likely to

be temporary, and not serious. However, some may be serious and

need medical attention.

The following side effects are important and will require

immediate action if you experience them.

You should stop taking Flucloxacillin Capsules and see your

doctor immediately if the following symptoms occur:

A sudden allergic reaction with shortness of breath, itchy rash,

itching, sore mouth or eyes, swelling of the face, lips, throat or

tongue

Watery, severe diarrhoea that may also be bloody

Jaundice (yellowing of the skin and eyes), hepatitis

(inflammation of the liver) - sometimes these effects on the

liver can be delayed for up t o 2 months after finishing

treatment

Severe skin rash with flushing, fever, blisters or ulcers

(Stevens-Johnson syndrome)

Severe rash with reddening, peeling and swelling of the skin

that looks like a burn (toxic epidermal necrolysis).

Serious skin reactions: A red, scaly rash with bumps under the

skin and blisters (exanthematous pustulosis). (Frequency not

known (frequency cannot be estimated from the available

data). Contact a doctor immediately if you get any of these

symptoms.

Tell your doctor if you notice any of the following effects:

Common: may affect up to 1 in 10 people

diarrhoea, minor stomach disturbances e.g. stomach upset and

feeling sick - should be mild and wear off after a few days

Uncommon: may affect up to 1 in 100 people

Rash, hives and pin-point bleeding areas in the skin

Very rare: may affect up to 1 in 10,000 people

difficulty passing water or blood in the urine (may be a sign of

inflammation of the kidney).

a fall in the number of cells in the blood leading to anaemia

(shortness of breath or looking pale), prone to infections and

easy bruising or bleeding.

joint or muscle pains or fever (may develop 2 days after

starting treatment).

Very rare cases of blood and fluid abnormality (high anion gap

metabolic acidosis) which occurs when there is an increase in

plasma acidity, when flucloxacillin is used concomitantly with

paracetamol, generally in the presence of risk factors (see

section 2).

Check with your doctor if you have any problems while taking this

medicine, even if you think the problems are not connected with

the medicine, or are not listed in this leaflet.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This

includes any possible side effects not listed in this leaflet. You can

also report side effects directly via the Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA

Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information

on the safety of this medicine.

What is in this leaflet:

1. What Flucloxacillin Capsules are and what are they used for

2. What you need to know before you take Flucloxacillin Capsules

3. How to take Flucloxacillin Capsules

4. Possible side effects

5. How to store Flucloxacillin Capsules

6. Contents of the pack and other information

1.

What Flucloxacillin Capsules are and what are they used

for

Flucloxacillin is an antibiotic used to treat infections by killing

bacteria that can cause them. It belongs to a group of antibiotics

called “penicillins”.

Flucloxacillin is used to treat:

chest infections

throat or nose infections

ear infections

skin and soft tissue infections

heart infections

bone and joint infections

meningitis

digestive system infections

blood infections

kidney, bladder or urethra (the tube which carries urine from

the bladder) infections.

Flucloxacillin may also be used to prevent infections during major

surgery, particularly heart or orthopaedic surgery.

2.

What you need to know before you take Flucloxacillin

Capsules

Do not take Flucloxacillin Capsules if:

You are allergic to flucloxacillin or any other penicillin

antibiotics (see symptoms in section 4).

You are allergic to any of the other ingredients of this medicine

(listed in section 6).

You have suffered previously from liver problems (e.g.

jaundice) after taking flucloxacillin.

Warnings and precautions

Talk to your doctor or pharmacist before taking Flucloxacillin

Capsules if:

You are taking or will be taking paracetamol

There is a risk of blood and fluid abnormality (high anion gap

metabolic acidosis) which occurs when there is an increase in

plasma acidity, when flucloxacillin is used concomitantly with

paracetamol, particularly in certain groups of patients at risk,

e.g. patients with severe renal impairment, sepsis or

malnutrition, especially if the maximum daily doses of

paracetamol are used. High anion gap metabolic acidosis is a

serious disease that must have urgent treatment.

You suffer from kidney problems, as you may require a lower

dose than normal

You suffer from liver problems, as this medicine could cause

them to worsen

You are 50 years of age or older

You have other serious illnesses (apart from the infection this

medicine is treating)

You are taking this medicine for a long time as regular tests of

liver and kidney function are advised

You are on a low sodium diet

Other medicines and Flucloxacillin Capsules

Tell your doctor or pharmacist before taking this medicine if you

are taking any other medicines, especially:

Probenecid or sulfinpyrazone (used to treat gout)

Methotrexate (a chemotherapy drug)

The contraceptive pill as antibiotics can make these less

effective (you will need to use extra precautions such as

condoms while taking flucloxacillin and for a full 7 days after

you finish taking it)

Oral typhoid vaccine (antibiotics can make this less effective)

Sugammadex (used with general anaesthetics)

Piperacillin (an antibiotic taken by injection)

Warfarin (medicine to prevent blood clotting)

Some medicines may affect the way others work. Tell your doctor

or pharmacist if you are taking, have recently taken or might take

any other medicines. This means medicines you have bought

yourself as well as medicines on prescription from a doctor.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant

or are planning to have a baby, ask your doctor or pharmacist for

advice before taking this medicine.

Driving and using machines

Flucloxacillin Capsules should not affect your ability to drive or

operate machinery

Flucloxacillin Capsule contains sodium

Each 250mg capsule contains 13mg of sodium and each 500mg

capsule contain 25mg of sodium. To be taken into consideration by

patients on a controlled sodium diet.

3.

How to take Flucloxacillin Capsules

Always take this medicine exactly as your doctor or pharmacist

has told you.

Their directions may differ from the information contained in this

leaflet. The pharmacist’s label should tell you how much to take

and how often. Check with your doctor or pharmacist if you are

not sure.

Take this medicine when your stomach is empty. This means an

hour before food or 2 hours after food. It is important that you take

your medicine at the right times. The capsules should be

swallowed whole with water.

The dose will depend on the patient and will be decided by your

doctor. However, the usual doses for each age group are:

Adults including older patients

The usual dose for adults, older patients and children over 10 years

old is one 250 mg capsule four times a day. Your doctor may

increase the dosage depending on your infection.

For bone or heart infections the dose is up to 8g daily, in divided

doses at six to eight hours apart.

For preventing infections during surgery the dose is 1 to 2g given

into a vein at the same time as anaesthesia followed by 500 mg

every six hours for up to 72 hours.

Use in children

For children 2 to 10 years old the dose is half of the adult dose. For

children under 2 years old the dose is quarter of the adult dose.

Your doctor may prescribe a syrup formulation for children

younger than 10 years.

Patients with kidney problems

If you suffer from severe kidney failure your doctor will give you

lower or fewer doses.

If you take more Flucloxacillin Capsules than you should

If you have taken more capsules than you should, talk to your

pharmacist or doctor immediately.

5.

How to store Flucloxacillin Capsules

Keep this medicine out of the sight and reach of children.

Do not store above 25°C. Store in the original pack.

Do not use Flucloxacillin Capsules after the expiry date which is

stated on the carton or label after EXP. The expiry date refers to

the last day of that month.

Do not throw away any medicines via wastewater or household

waste. Ask your pharmacist how to throw away medicines you no

longer use. These measures will help to protect the environment.

6.

Contents of the pack and other information

What Flucloxacillin Capsules contain:

The active substance in Flucloxacillin 250 mg & 500 mg

Capsules is flucloxacillin sodium.

The other ingredients are Colloidal anhydrous silica,

Magnesium stearate, gelatin, Black Iron oxide (E172),

Titanium dioxide (E171), Iron Oxide Red (E172), Iron Oxide

Yellow (E172). The white ink contains titanium dioxide

(E171), Shellac, Tween 80.

What Flucloxacillin Capsules look like and contents of the

pack

Flucloxacillin 250 mg Capsules are caramel and black and are

printed with the words ‘FLU250MIL’

Flucloxacillin 500 mg Capsules are caramel and black and printed

with the words ‘FLU500MIL’

Flucloxacillin 250 mg Capsules are available in blister packs

containing 20 or 28 Capsules.

Flucloxacillin 500 mg Capsules are available in blister packs

containing 20 or 28 Capsules.

Not all pack sizes may be marketed.

This leaflet was last revised in July 2018.

Marketing Authorisation Holder and Manufacturer:

NOUMED LIFE SCIENCES LIMITED

Noumed House, Shoppenhangers Road,

Maidenhead, Berkshire, SL6 2RB, United Kingdom

To listen to or request a copy of this leaflet in

braille, large print or audio,

please call 020 33 99 8960 (UK only).

Please be ready to give the following information

Product name

Reference number

Flucloxacillin 250 mg Capsules PL 44041/0017

Flucloxacillin 500 mg Capsules PL 44041/0018

If you forget to take Flucloxacillin Capsules

If you have missed a dose, do not take a double dose to make up

for the missed dose. If you forget to take a dose take it as soon as

you remember it and carry on as before.

If you stop taking your medicine

Keep taking your medicine until your doctor tells you to stop. Do

not stop taking it just because you feel better. If you stop taking

the medicine, your infection may return or get worse. If you are

still unwell after taking all the medicine, go and see your doctor.

If you have any further questions on the use of this medicine, ask

your doctor or pharmacist.

4.

Possible side effects

Like all medicines, Flucloxacillin Capsules can cause side effects,

although not everybody gets them. If they occur, they are likely to

be temporary, and not serious. However, some may be serious and

need medical attention.

The following side effects are important and will require

immediate action if you experience them.

You should stop taking Flucloxacillin Capsules and see your

doctor immediately if the following symptoms occur:

A sudden allergic reaction with shortness of breath, itchy rash,

itching, sore mouth or eyes, swelling of the face, lips, throat or

tongue

Watery, severe diarrhoea that may also be bloody

Jaundice (yellowing of the skin and eyes), hepatitis

(inflammation of the liver) - sometimes these effects on the

liver can be delayed for up t o 2 months after finishing

treatment

Severe skin rash with flushing, fever, blisters or ulcers

(Stevens-Johnson syndrome)

Severe rash with reddening, peeling and swelling of the skin

that looks like a burn (toxic epidermal necrolysis).

Serious skin reactions: A red, scaly rash with bumps under the

skin and blisters (exanthematous pustulosis). (Frequency not

known (frequency cannot be estimated from the available

data). Contact a doctor immediately if you get any of these

symptoms.

Tell your doctor if you notice any of the following effects:

Common: may affect up to 1 in 10 people

diarrhoea, minor stomach disturbances e.g. stomach upset and

feeling sick - should be mild and wear off after a few days

Uncommon: may affect up to 1 in 100 people

Rash, hives and pin-point bleeding areas in the skin

Very rare: may affect up to 1 in 10,000 people

difficulty passing water or blood in the urine (may be a sign of

inflammation of the kidney).

a fall in the number of cells in the blood leading to anaemia

(shortness of breath or looking pale), prone to infections and

easy bruising or bleeding.

joint or muscle pains or fever (may develop 2 days after

starting treatment).

Very rare cases of blood and fluid abnormality (high anion gap

metabolic acidosis) which occurs when there is an increase in

plasma acidity, when flucloxacillin is used concomitantly with

paracetamol, generally in the presence of risk factors (see

section 2).

Check with your doctor if you have any problems while taking this

medicine, even if you think the problems are not connected with

the medicine, or are not listed in this leaflet.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This

includes any possible side effects not listed in this leaflet. You can

also report side effects directly via the Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA

Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information

on the safety of this medicine.

SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT

Flucloxacillin Capsules BP 250mg

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

Flucloxacillin Sodium BP 250mg equivalent to 250mg Flucloxacillin

3

PHARMACEUTICAL FORM

Capsules.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications

Flucloxacillin Sodium is used for the treatment of infections due to

staphylococci resistant to benzylpenicillin. It is also used for mixed

streptococcal and staphylococcal, infections when the staphylococci are

penicillin-resistant.

Typical indications include: skin and soft tissue infections (boils, abscesses,

carbuncles, furunculosis, cellulitis, infected wounds, infected burns,

protection for skin grafts, otitis media and externa), respiratory tract infections

(pneumonia, lung abscess, empyema, sinusitis, pharyngitis, tonsillitis, quinsy).

Other infections include: osteomyelitis, enteritis, endocarditis, urinary tract

infections, meningitis and septicaemia.

4.2

Posology and method of administration

Dosage should be taken half to one hour before food.

Adults:

(Dosage for all indications except osteomyelitis, endocarditis, and surgical

prophylaxis).

The equivalent of 250mg (1 x 250mg capsule) of flucloxacillin by mouth 4

times a day. However dose may be doubled in severe infections (1 x 500mg

capsules 4 times a day).

Osteomyelitis, endocarditis: Up to 8g daily in divided doses 6-8 hourly.

Children:

2-10 years: One half the adult dose administered in syrup form. For children

under 2 years, capsules are not suitable.

Elderly patients:

As for adults, except where there is severe renal impairment. In these cases

dosage may have to be reduced.

Route of administration: Oral.

4.3

Contraindications

Flucloxacillin Sodium is contraindicated in patients known to be

hypersensitive to penicillins and should be given with caution to patients with

a known history of allergy.

4.4

Special warnings and precautions for use

Flucloxacillin should be given with caution to patients with a history of allergy.

Preparations should be made to deal with anaphylactic shock before the first dose is

given. Care is necessary where large doses of sodium salts are given to patients with

impaired renal function or congestive heart failure. Contact with penicillins should

be avoided since skin sensitisation may occur.

4.5

Interaction with other medicinal products and other forms of interaction

When concomitantly administered with oral contraceptives, the contraceptives

have a reduced effect. Serum concentrations are enhanced if Probenecid is

given concomitantly.

4.6

Fertility, Pregnancy and lactation

Flucloxacillin diffuses across the placenta into the foetal circulation and is

excreted in the milk of nursing mothers. It may provoke allergic reactions in

infants that are allergic to penicillins. Flucloxacillin can be used in pregnant

mothers, if necessary.

4.7

Effects on ability to drive and use machines

Not applicable.

4.8

Undesirable effects

When Flucloxacillin Sodium is administered to a hypersensitive patient,

anaphylactic shock with collapse and sometimes death may occur within

minutes. A generalised sensitivity reaction can occur within 1-3 weeks with

urticaria, fever, eosinophilia, joint pains, angioneurotic oedema, erythema

multiforme, and exfoliative dermatitis, although an accelerated urticarial

reaction can develop within hours.

Convulsions and other signs of toxicity to the central nervous system may

occur with very high doses of Flucloxacillin particularly when administered to

infants and the elderly, and to patients with renal failure. Administration of

Flucloxacillin by mouth is liable to produce transient diarrhoea and sometimes

nausea, heartburn and pruritis ani. Skin rashes may occur. If a rash occurs,

treatment should be discontinued.

Hepatitis and cholestatic jaundice have been reported occasionally with

Flucloxacillin and may be delayed in onset. Older patients and those receiving

flucloxacillin for more than two weeks are at greater risk.

4.9

Overdose

Serious symptoms are unlikely. Treatment should be symptomatic. Patient

should be kept under observation.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Flucloxacillin Sodium, like other isoxazolyl penicillins, is a potent inhibitor of

the growth of most penicillinase-producing staphylococci. This agent, in

general, is less effective against micro-organisms susceptible to penicillin G

and are not as useful against gram-negative bacteria.

Flucloxacillin Sodium is bactericidal. It is considered to act by inhibiting

transpeptidase, the enzyme responsible for cross-linking of peptidoglycan

during the final stages of synthesis of the bacterial cell wall and so exerts its

effects against dividing bacteria. It is active against most gram-positive

organisms and neisseria spp.

On the basis of minimum inhibitory concentrations, its activity against both

penicillin-resistant and penicillin-sensitive staphylococci is 4 to 8 times that of

methicillin sodium, but against penicillin-sensitive staphylococci, its activity is

only about one quarter that of benzylpenicillin or phenoxymethyl-penicillin.

A minimum inhibitory concentration against penicillin-resistant staphylococci

of 0.25-0.5

g/ml has been reported. Its activity against streptococci is less

than that of benzylpenicillin but sufficient to be useful when these organisms

are present with penicillin-resistant staphylococci.

Resistance to Flucloxacillin has developed in both penicillinase and non-

penicillinase producing staphylococci with cross resistance to other

penicillins, including the penicillinase-resistant penicillins such as cloxacillin,

nafcillin and oxacillin; to the cephalosporins and to other antibiotics including

chloramphenicol, erythromycin, tetracycline, kanamycin, streptomycin, and

lincomycin. This resistance is intrinsic and unrelated to penicillin production.

5.2

Pharmacokinetic properties

Flucloxacilin Sodium is better absorbed from the gastrointestinal tract than

cloxacillin sodium but absorption is also reduced by food in the stomach or

small intestine. After an oral dose of 250mg to 500mg, in fasting subjects,

peak serum concentrations in about 1 hour may range from 3 to 27

g per ml

with mean peak concentrations of about 11 to 15

g per ml. A therapeutic

concentration persists for about 4 hours. Doubling the dose can double the

plasma concentration. Some 50% of a dose by mouth is excreted in the urine

within 6 hours, serum concentrations are enhanced if probenecid is given

concomitantly.

About 90-95% of Flucloxacillin in the circulation is bound to plasma albumin

to a greater extent, none is removed from the circulation to a significant degree

by haemodialysis.

The isoxazolyl penicillins, like Flucloxacillin, are rapidly excreted by the

kidney. There is also significant hepatic elimination of these agents in the

bile. The half life of Flucloxacilin is between 30-60 minutes.

5.3

Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are

additional to that already included in other sections of the SPC.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Magnesium Stearate

Colloidal Anhydrous Silica

Capsule Shell Components:

Body:

Red Iron Oxide E172

Yellow Iron Oxide E172

Methyl Paraben E218

Propyl Paraben E216

Titanium Dioxide E171

Gelatin

Cap:

Black Iron Oxide E172

Titanium Dioxide E171

Methyl Paraben E218

Propyl Paraben E216

Gelatin

Ink components:

Titanium Dioxide

Shellac

Isopropyl Alcohol

Alcohol

Industrial Methylated Spirits

Purified Water

N-butyl Alcohol

Soya Lecithin

Antifoam DC 1510

6.2

Incompatibilities

None stated

6.3

Shelf life

24 months: polypropylene containers

12 months: blister strips

6.4

Special precautions for storage

Store in tightly closed containers in a dry place, at a temperature not exceeding

6.5

Nature and contents of container

6.6

Special precautions for disposal

White polypropylene container with polyethylene lid: 14, 28, 100, 250, 500

and 1000 capsules.

Blister Strips: 14 and 28 capsules.

7

MARKETING AUTHORISATION HOLDER

Pharmaclarity Limited

Bemin House Cox Lane,

Chessington Industrial Estate

Chessington

Surrey

England

KT9 1SG

8

MARKETING AUTHORISATION NUMBER(S)

PL 48134/0018

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

9th August 1991/7th October 1996

10

DATE OF REVISION OF THE TEXT

31/08/2017

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